George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...

"This risk is exacerbated by the fact that there is currently no proven, widely accepted standard to determine marijuana ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

An FDA panel of experts has called for a loosening of regulations and expanding access to testosterone replacement therapy.

A regulation with potentially major implications for the pharmaceutical industry has cleared its review, teeing it up for ...

Dr. Helen Bernie said on a Dec. 10 panel hosted by the U.S. Food and Drug Administration that serum testosterone "is one of ...

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER), continuing the rapid ascent of a physician who rose to prominence during the ...

The FDA is being transformed from an independent regulator into a high-stakes bargaining chip for White House deal-making.